Duns Number:001307735
Device Description: Transwell, organogenesis, 75MM, 3.0PC,NT,OX,HTD BD,S,IND,1/48
Catalog Number
7425
Brand Name
Costar
Version/Model Number
7425
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KIZ
Product Code Name
DISH, TISSUE CULTURE
Public Device Record Key
1e36eacf-6287-49f5-b945-59ed219e1ba4
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
March 15, 2022
Package DI Number
H10874253
Quantity per Package
48
Contains DI Package
H10874251
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 387 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |